Use of Risperidone in ECT for Treatment Resistant Depression

This study has been terminated.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00203723
First received: September 13, 2005
Last updated: May 17, 2006
Last verified: May 2006
  Purpose

The purpose of this study is to determine if the combination of risperidone and ECT improves a patient's response in depression compared to ECT alone.


Condition Intervention Phase
Major Depression
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison Study of Combined ECT and Risperidone Versus ECT Alone for Treatment Resistant Depression.

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Scores on depression scales after 6 ECT treatments

Secondary Outcome Measures:
  • Scores on Clinical Global Impression Scales and Symptom Checklist

Estimated Enrollment: 45
Study Start Date: March 2005
Estimated Study Completion Date: May 2006
Detailed Description:

Medication resistance to antidepressant therapy, or Treatment-Resistant Depression (TRD), is the main reason, if not main indication, for which patients are presently referred for electroconvulsive therapy (ECT) in hopes of a rapid, definitive response (APA 2001 ECT Task Force Report). While the causes of TRD remain unclear, this category of patients includes those who have incomplete remission, those who relapse rapidly and frequently, those who have psychotic depression, those who develop chronic depression, and those who often have comorbid medical and psychiatric illness (Sackeim 2001, Sharma 2001, Fava and Davidson 1996, Thase 1995). Moreover, while increased age per se is not a barrier to antidepressant response, many elderly, especially those with comorbid medical or neurological illness, are unable to tolerate courses of aggressive pharmacotherapy or seem to have a less robust response to pharmacotherapy, and possibly to ECT alone, with significant residual functional and cognitive impairment (Reynolds 1998, Stoudemire 1998, Lebowitz 1997, Gurland 1991).

Compared to patients who are not medication resistant, who generally retain the highest likelihood of response to ECT alone, patients with TRD have a lower response rate to ECT with average estimates of response to ECT alone between 50-60% (APA 2001 ECT Task Force). Additionally, while ECT for most patients may provide acute remission, those patients with TRD remain at high risk for rapid relapse (Sackeim 2001, Petrides 2001, Sackeim 1990, Aronson 1987). Consequently, ECT alone may be insufficient to achieve remission or to prevent relapse. Interestingly, resistance to some types of medication was found also to predict resistance to ECT alone, i.e., resistance to tricyclic antidepressants correlated with a less likely response to ECT, though the same prediction did not hold for serotonin reuptake inhibitors (Prudic 1996, Prudic 1990).

In general, for some patients with TRD, studies support the use of combined medication approaches, and specifically, have demonstrated the safety, tolerability and effectiveness of an antidepressant with an antipsychotic medication, though usually for patients with comorbid psychosis (Wheeler 2000, Shelton 1999, Barak 1999). Case reports exist in the ECT literature about the safety and tolerability of ECT and antipsychotics, and improved efficacy, albeit generally for patients with psychotic depression or other treatment resistant psychoses (Kupchik 2000, Bhatia 1998, Ranjan 1996, Farah, Beale, and Kellner 1995, Minter 1979). However, no studies systematically, or prospectively, investigate whether the specific combination of ECT plus an atypical antipsychotic offers a true treatment alternative to improved efficacy of ECT for patients with TRD.

This study reviews the experience and outcome of combining ECT and an atypical antipsychotic medication, risperidone, for TRD in various populations in an academic, university-based setting, and furthermore, explores in a pilot randomized open-label study whether ECT plus risperidone bears closer scrutiny in more rigorous study designs as a novel treatment approach.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 to 89 years, inclusive
  • Male or female
  • Inpatient or outpatient ECT with a current diagnosis of unipolar or bipolar depression, with or without psychosis, according to DSM-IV criteria. HAM-D (17-item) score > 17 and MADRS score > 18 at screening and at first treatment session.

Exclusion Criteria:

  • MMSE < 23
  • Inability to consent to ECT
  • Current diagnosis of schizophrenia or schizoaffective disorder
  • Current diagnosis of Parkinson’s Disease or any Dementia, including Lewy Body Disease
  • History of allergic reaction to risperidone
  • History of Neuroleptic Malignant Syndrome
  • Current pregnancy or positive urine pregnancy test
  • Women who are breast-feeding
  • Active alcohol or illicit substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203723

Locations
United States, California
UCLA Npi&H
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Janssen, LP
Investigators
Principal Investigator: Randall Espinoza, MD, MPH University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203723     History of Changes
Other Study ID Numbers: UCLA IRB #03-10-049-01, RIS-DEP-405
Study First Received: September 13, 2005
Last Updated: May 17, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
mood disorder
affective disorder
depression
treatment-resistant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 26, 2014